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Safety and efficacy of bimekizumab for PsA up to 52 weeks: BE VITAL open-label extension

Apr 2, 2024
Learning objective: After reading this article, learners will be able to cite a new clinical development in psoriatic arthritis.

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Psoriatic arthritis (PsA) can occur across multiple domains, with treatment aiming to achieve optimal outcomes in all affected domains. Tumor necrosis factor inhibitors (TNFi) are often used as a first-line treatment in patients with active PsA; however, there is a population of patients who do not yield an adequate response to TNFi. 

Here, we summarize an article by Coates et al.1 published in RMD Open on the results up to Week 52 in the BE VITAL open-label extension (OLE), which followed on from the Phase III BE COMPLETE trial. BE VITAL investigated the long-term safety and efficacy of bimekizumab, an anti-interleukin 17 antibody. This analysis focuses on patients who do not yield an adequate response to TNFi. 

Study design1 

  • BE COMPLETE was a 16-week phase III placebo-controlled trial. Additional information about BE COMPLETE has previously been published on the Psoriasis and Psoriatic Arthritis Hub. 

  • Patients who completed the BE COMPLETE trial entered the BE VITAL OLE, in which patients received bimekizumab 160mg every 4 weeks for up to 140 weeks 

  • Included patients who had active PsA with a baseline tender joint count ≥3, swollen joint count ≥3, and ≥1 active psoriatic lesion and/or a history of psoriasis.  

  • Intolerance or an inadequate response to one or two TNFi for the treatment of psoriatic disease was required. 

Key findings1 

  • A total of 377 patients (256 randomized to bimekizumab and 12 randomized to placebo) were included in the BE VITAL OLE. 

  • Efficacy, as measured by American College of Rheumatology scores and Psoriasis Area and Severity Index, was improved compared with placebo at Week 16, and sustained to Week 52 in patients treated with bimekizumab (Figure 1). 

  • In patients who switched to bimekizumab from placebo, rapid improvements in American College of Rheumatology scores occurred after 12 weeks of treatment and were observed up to Week 52.  

  • To Week 52, the most common treatment-emergent adverse events in patients treated with bimekizumab were COVID-19 infection (7.2%), oral candidiasis (6.2%), nasopharyngitis (5.9%), and urinary tract infection (5.9%). 

  • All Candida infections in bimekizumab-treated patients were of mild or moderate severity. 

  • There was one sudden death and one cerebral hemorrhage during BE VITAL, which were unrelated to the study treatment. 

Figure 1. Efficacy outcomes (ACR 50, PASI 90, and MDA) at A Week 16 and B Week 52* 

ACR 50, 50% improvement in American College of Rheumatology score; BKZ, bimekizumab; MDA, minimal disease activity; PASI 90, 90% improvement in Psoriasis Area and Severity Index. 
*Data from Coates, et al.1 


Key learnings

  • In patients with active PsA who do not yield an adequate response to TNFi, treatment with bimekizumab (including switching to bimekizumab from placebo) led to sustained meaningful improvements in efficacy outcomes up to Week 52.  

  • Bimekizumab was well-tolerated, with a safety profile comparable with that seen in previous trials. 

  • BE VITAL will continue to Week 140, providing longer-term safety and efficacy data. 

  1. Coates LC, Landewé R, McInnes IB, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10(1):e003855. DOI: 10.1136/rmdopen-2023-003855 


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